Health TrialsbyHealthPanel

Cardiovascular Kidney and Metabolic Health Assessment and Patient Empowerment

ConditionsAcute MIHeart FailureDiabetes MellitusKidney Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAventyn, Inc.

About this trial

The primary objective of CHAPERONE solution is to evaluate the efficacy of engaging, assessing, and enabling long term treatment strategy with Health Artificial Intelligence (AI) Chatbot, Copilot, Large Language Model (LLM) and vital sign monitoring device in reducing CKM disease burden using an algorithm obtained from biomarkers and diagnostics utilizing remote sensor driven technology tools, care coordination and patient empowerment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women over 18 years of age are included

Diabetes with A1C of 7.5 or higher;

or Heart disease with stent placement;

or Coronary Artery Bypass Graft (CABG) in the last 12 months;

Disqualifiers

Those subjects who are not willing to sign an informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • CHAPERONE AI

    Other intervention

    The primary objective of this study is to evaluate the efficacy of treatment strategy on the impact of an intervention that is AI, Machine Learning (ML) based using Chatbot and Copilot with algorithm based intervention in CKM subjects in reducing progression of CKM diseases. This will be based on an algorithm obtained from biomarkers and diagnostics utilizing remote sensor driven technology tools, care coordination and patient empowerment. Improvement of patient outcomes will be measured by reduction of composite of Kidney failure/progression of kidney disease, Heart failure, acute myocardial infarction (AMI) events and diabetes complications and hospitalization as well as all-cause mortality through 30 days, 90 days and 180 days in CKM patients

  • CKMiq AI

    Device

    To evaluate the effect of treatment in: reducing readmission's from cardiovascular causes using an algorithm-based intervention of LIFE ESSENTIAL 8 biomarkers obtained from info graphic resources provided by American Heart Association. Improving subject self-assessed risk score overall well-being as measured by self-assessed Copilot Likert scale at 30 days, 90 days and 180 days from hospitalization. Increasing the number of days alive and outside the hospital from hospitalization through day 30, 90 and Day 180. Reducing the composite of cardiovascular re-hospitalization and cardiovascular mortality from hospitalization through 30, 90 and 180 days. New York Heart Association (NYHA) Class and Kansas City Cardiomyopathy Questionnaire (KCCQ) will be captured.

  • Quality of Life

    Other intervention

    Secondary and tertiary objectives of this study are to evaluate the effect of CHAPERONE intervention in: Improving LIFE ESSENTIAL-8 Score and Health Related Quality of Life (HRQOL) measured with the 12-item Short Form (SF-12) survey, which reflects general health status and leads to 2 scores

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: InterventionPlacebo comparator 3 interventions
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

CHAPERONE AI Treatment

Improvement of patient outcomes will be measured by reduction of composite of Kidney failure/progression of kidney disease, Heart failure, Acute Mi events and diabetes complications and hospitalization as well as all-cause mortality through 30 days, 90 days and 180 days in patients CKM

Time frame
30 days, 90 days and 180 days in patients CKM

Secondary outcomes

1

CHAPERONE AI Reduced Readmissions

educing readmissions from cardiovascular causes using an algorithm-based intervention of LIFE ESSENTIAL 8 biomarkers obtained from infographic resources provided by American Heart Association , improving subject self-assessed risk score overall well-being as measured by self-assessed Copilot Likert scale at 30 days, 90 days and 180 days from hospitalization Increasing the number of days alive and outside the hospital from hospitalization through day 30, 90 and Day 180. Reducing the composite of cardiovascular re-hospitalization and Cardiovascular mortality from hospitalization through 30, 90 and 180 days. NYHA class and KCCQ will be captured

Time frame
30, 90 and 180 days.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aventyn, Inc.

Lead sponsor

Dignity Health

Collaborator

Arizona Heart Foundation

Collaborator

Arizona State University

Collaborator

University of Arizona

Collaborator

University of Phoenix College of Nursing

Collaborator

Creighton School of Medicine, Phoenix Arizona

Collaborator

Karolinska University Hospital

Collaborator

Partnership for Economic Innovation Arizona

Collaborator

Kanasu Labs

Collaborator

Intel Corporation

Collaborator

Source ClinicalTrials.gov
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